A Placebo- and Paroxetine-Controlled Study of the Efficacy, Safety and Tolerability of Agomelatine (25 or 50 mg) in the Treatment of Major Depressive Disorder (MDD) - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00463242

Purpose

This study will evaluate the efficacy, safety and tolerability of agomelatine 25 mg or 50 mg per day and will compare agomelatine and paroxetine tolerability. Eligible patients will receive double-blind study medication for 8 weeks. One week after completion of the double-blind treatment phase there will be a single follow-up visit.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: agomelatine Drug: paroxetine Drug: placebo	Phase III

MedlinePlus related topics: Depression

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine Mesylate S 20098

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An 8-Week, Multicenter, Randomized, Double-Blind, Placebo- and Paroxetine-Controlled Study of the Efficacy, Safety and Tolerability of Agomelatine 25 or 50 mg Given Once Daily in the Treatment of Major Depressive Disorder (MDD) Followed by a 52-Week Open-Label Treatment With Agomelatine 25 or 50 mg

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from Baseline to Week 8 on the total score Hamilton Depression Rating Scale

Secondary Outcome Measures:

To demonstrate less sexual dysfunction in patients with MDD receiving agomelatine compared to paroxetine, as measured by the change from baseline to Week 8 on the total score of the Arizona Sexual Experience Scale (ASEX).
Proportion of patients who demonstrate clinical improvement where improvement is defined by a score of 1 or 2 on the Clinical Global Impression Improvement (CGI-I) scale at Week 8.
Proportion of patients with MDD who achieve remission,
Change from baseline to Week 8 on the total score and Anxiety subscale of the Hospital Anxiety and Depression Scale (HAD).

Estimated Enrollment:	490
Study Start Date:	March 2007
Estimated Study Completion Date:	June 2009

Arms	Assigned Interventions
1: Experimental	Drug: agomelatine
2: Active Comparator	Drug: paroxetine
3: Placebo Comparator	Drug: placebo

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Male and female adults, 18 through 70 years of age, inclusive
Diagnosis of Major Depressive Disorder according to DSM-IV criteria
HAM-D17 total score > or = 22 at Screening and Baseline

Exclusion Criteria:

History of non-response to paroxetine
Patients who have been previously treated with agomelatine
History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder
Any current Axis I disorder other than major depressive disorder which is the focus of treatment
Substance or alcohol abuse in the last 30 days, dependence in the last 6 months
Use of any psychoactive medication after the screening visit
Female patients of childbearing potential who are not using effective contraception

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463242

Locations

United States, California
Novartis Investigative Site
Pasadena, California, United States, 91105

Sponsors and Collaborators

Novartis

More Information

Please click here for more information on this study This link exits the ClinicalTrials.gov site

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CAGO178A2303
Study First Received:	April 19, 2007
Last Updated:	April 1, 2008
ClinicalTrials.gov Identifier:	NCT00463242
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

agomelatine, Major Depressive Disorder, MDD, depression

Study placed in the following topic categories:

S 20098
Depression
Mental Disorders
Mood Disorders
Depressive Disorder, Major

Depressive Disorder
Paroxetine
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Serotonin Uptake Inhibitors

Pharmacologic Actions
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Hypnotics and Sedatives
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009